A Breath of Fresh Air

Respiratory drug delivery systems are getting a tech makeover and rapidly advancing toward better outcomes. Now is the time to learn more.

• By Holly J. Wagner
• Apr 01, 2019

Nebulizers and oxygen systems have been around for decades, and they’ve helped improve the lives of countless patients. But with self-administered treatments comes the risk that patients will use the treatments improperly or stop using them at all. That, of course, can lead to emergencies, hospitalizations and worse.

Everyone agrees that compliance is the key to the best outcomes. For the DME pharmacy that means helping the patient find the most comfortable and practical system for their lifestyle; often that means the most portable system. Patients put a high premium on smaller, lighter and shortest possible medication delivery time, but also value equipment that’s reliable and quiet. In other words, as unobtrusive as possible.

“It is not uncommon for patients with respiratory diseases to spend a lot of time taking their treatments, including equipment setup, administration and cleaning after each use. Some patients may administer several different treatments each day, which can add up to several hours revolving around managing their illness,” says Linda Trevenen, business leader for respiratory drug delivery at Philips. “We also recognize that older patients with COPD may have difficulty using a wide range of aerosol devices effectively because of their comorbidities and cognitive and physical impairments.”

IMPROVING COMPLIANCE — AND DELIVERY

Dr. Ralph Finger wanted to eliminate all that for his young, asthmatic daughter a few years ago, so he developed the FLYP Nebulizer which is produced by Convexity Scientific Inc.

“A very big issue with treating any disease is compliance. If someone doesn’t take their medication, they’re not going to get better. If it is not easy for people to take their medication, they’re generally not going to take it,” he says. “A big part of what we are trying to do is introduce a device that will get the patient to take the medication.”

Beyond getting your patient to keep up the regimen, the key to proper inhaled medication is the particle size, he says. “The challenges of getting drugs into the lungs are getting the solutions into fine enough particles to inhale, and making sure the particles are the right size,” Finger says. “There is a challenge to create a uniform mist with 2-3 micron particles.” The Flyp tackles that with an internal, perforated disk that vibrates at ultrasonic speed. When medication passes through the disk’s holes, it produces an inhalable aerosol mist, with the time needed to dispense medication shortened to about seven minutes for most medications.

The Flyp device has been FDA-cleared for use with any medication intended for a general-purpose nebulizer, such as albuterol, ipratropium bromide, cromolyn sodium, and budesonide, in addition to other medications. It is powered by a lithium-ion battery that recharges via micro USB. It gets eight to 10 treatments on a full charge, which takes roughly an hour and a half.

Portability makes a big difference to patients, but it’s not everything. “Adherence and poor usability remain a challenge,” Trevenen says. “One strategy for managing both issues is connecting drug delivery devices through the use of mobile applications. A connected drug delivery solution provides a more usable and learnable device that better fits into patients’ lifestyles. Likewise, a connected solution addresses payer needs of measurements of results and compliance data to justify spending.”

Most DME pharmacy clients using home respiratory aids or drug delivery will be asthma, COPD and cystic fibrosis patients. A significant portion of these patient groups is youngsters and elders who might have trouble managing, or even remembering, their medications. To help keep patients on their feet, manufacturers are offering a new wave of respiratory drug delivery devices equipped with features that help improve the delivery and measure performance of the device — and in some cases, the patient.

MONITORING USAGE

“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should,” says Tushar Shah, M.D., global head of Specialty Clinical Development & Medical Affairs at Teva Pharmaceuticals. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.” Patients four years and older can use the device, so the data can also help parents manage their children’s conditions.

Device monitoring now also aims to help the patient before he or she needs a scheduled (or unscheduled) visit to the doctor. “Digital medicines provide patients with a greater sense of control over their disease by placing the tools to self-manage in the palm of their hand,” says Chris Hogg, chief commercial officer for Propeller Health. “With a digital medicine, a patient can use their smartphone or computer to remind them to take their medicine, understand when and where they’ve been experiencing exacerbations, communicate with their provider on their symptoms and gain insights into what triggers their exacerbations.”

Remote monitoring for respiratory devices started with CPAP and other sleep devices, but the data produced and recent technology developments like Bluetooth and 4G (soon 5G) opened new horizons for monitoring more portable devices. As Medicare demands ever more justification for treatments, solutions that can provide real data are increasingly popular.

“We’ve prioritized clinical outcomes since the beginning, including demonstrating improvement in medication adherence by 58 percent and symptom-free days by 48 percent,” Hogg says.

Propeller Health’s product isn’t a nebulizer or inhaler; it’s a set of easy-to-attach sensors the patient installs on any existing inhaled medication device, paired with a web or phone app the patient can use to monitor their own behavior and share information with caregivers. The sensors track the patient’s medication usage and send it to the app, which crunches the data and presents it to the patient in graphic form. The patient dashboard uses GPS data to monitor environmental factors like weather and air quality as well as medication schedules and symptom incidents. The app produces reports the patient can take to a doctor or therapist to manage treatment.

“The types of medicine that can be paired with a digital companion vary by company and disease state. Propeller covers more than 90 percent of the inhaled medications for asthma and COPD on the market, including widely used medicines from GSK, Novartis and Boehringer Ingelheim,” Hogg says. “Propeller’s platform connects to both rescue medications, which work quickly to relieve asthma symptoms, and controller medications, which patients take persistent asthma.”

At least for now, there really isn’t a role for DME pharmacies in PropellerHealth’s business model. The company works with clinical, PBM and pharma partners for referrals and to cover the cost of the devices and monitoring, a company spokeswoman says. But DMEs are “a channel we are definitely exploring,” she says. “We are especially interested in the new Medicare payment rule around reimbursement for remote patient monitoring, and whether this will expand to cover DME pharmacy partners.”

Meantime, patients enroll on Propeller via the company’s website, through both clinical referral and direct-to-patient programs. Patients can sign up from home or in a doctor’s office. Once the patient enrolls in the program, they can download the app and are sent a sensor for their inhaler.

INTEGRATING THE RIGHT TECHNOLOGIES

Philips has offered respiratory equipment since the 1980s, and offers a range of newer products with high-tech features that aim to improve compliance through comfort and time saved.

“The focus has been to deliver solutions that are faster, quieter, and easier to use for the patient so that they have more time for life. Treating their respiratory disease does not have to stop a patient from doing what they love,” Trevenen says.

“Technology advancements such as miniaturization and the availability of electronic components have allowed for the evolution of the portable nebulizer market. Advances in fabrication processes such as electroforming have enabled the development of new vibrating mesh technology that is capable of producing droplets ≤3 microns of medication. Philips InnnoSpire Go portable mesh nebulizer uses this technology to deliver treatment in four minutes (2.5 ml Salbutamol). Not all meshes are fabricated from the same material, nor do they have the same design specifications. Differences in material and design will affect performance and reliability.”

Philips’ I-neb Adaptive Aerosol Delivery (AAD) System is a metered dose system. It uses a sensor to monitor the patient’s breathing pattern and adapt aerosol delivery during inhalation to deliver medications that require a precision dose delivery. Because the drug is only being delivered during inhalation, the technology minimizes drug waste compared to common jet nebulizers.

Sometimes, analog is best. The design of Philips’ OptiChamber VHC incorporates low-resistance valves to overcome problems with timing of pressurized metered dose inhalers (PMDI) actuation into inhalation. It lets patients breathe in normally through a mouthpiece instead of performing a special breathing technique. It’s especially suitable for young children, Philips says, because the small size lets them clear the drug from a chamber more quickly. It’s available with a flexible LiteTouch facemask that uses a comfort seal with a minimal amount of pressure to help get a better fit. The mask comes in three sizes and helps patients who can’t breathe through a mouthpiece.

The company’s range of SideStream nebulizers, for liquid medication delivery, provide a high-quality aerosol mist for delivery into the airways. The SideStream Plus is a design option that incorporates two valves that minimize waste of the drug during exhalation and boost medication delivery during inhalation, which reduces treatment time.

It’s not just nebulizers getting metered. OxyGo has offered its portable oxygen concentrators (POC) since 2015, but just this year rolled out OxyGo FIT Connect, a new wireless connectivity platform using Bluetooth technology. The free platform, always a planned companion feature for the device, includes a provider dashboard and mobile application for patient use through mobile devices.

“The new Bluetooth-enabled unit and patient app, in conjunction with a provider-focused and -designed back end, will improve patient outcomes by allowing patients and providers to communicate in real time about their POC,” says OxyGo CEO Victoria Marquard-Schultz.

The My OxyGo Provider Dashboard works with the My OxyGo App to provide real-time monitoring to help with troubleshooting, concentrator health checks, preventative maintenance and geo-locating of patients’ POCs. Providers and patients can check battery life, column life, oxygen purity and more with the touch of a button.

“OxyGo’s mission is to ‘Keep Going.’ This is just another tool in our kit to keep ambulatory oxygen patients moving and HMEs providing the state-of-the-art care required in this competitive market,” Marquard-Schultz says. An added benefit for DMEs: OxyGo does not sell direct to consumers and has an online referral engine for DME providers.

The latest entry into the respiratory drug delivery market is the ProAir Digihaler from Teva Pharmaceutical. The inhaler with built-in sensors won approval from the Food and Drug Administration (FDA) last December and is getting a limited rollout this year, with a national launch planned for 2020.

ProAir Digihaler contains sensors that detect when the inhaler is used and measure inspiratory flow. The inhaler use data is then sent to the companion mobile app using Bluetooth wireless technology, so patients can review their data over time and share it with their healthcare professionals. The device combines a breath-activated, multi-dose dry powder inhaler with albuterol — the most widely used asthma rescue medication — with a builtin electronic module and a companion mobile app, which provides inhaler use information to people with asthma and COPD.

The device helps patients and their caregivers better understand inhaler usage, says Sven Dethlefs, executive vice president of global marketing and portfolio at Teva. “The digital technology built into ProAir Digihaler provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.”

Teva says the ProAir Digihaler is available this year through a small number of “early experience” programs, conducted with healthcare systems and in limited areas, to gather real-world experience. A national launch is planned for next year.

This article originally appeared in the DME Pharmacy April 2019 issue of HME Business.